Lead Clinical Research Associate
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Job Description
Lead Clinical Research Associate overseeing country-level trial quality, compliance, monitoring, and team coordination remotely for PSI, a contract research organization.
Responsibilities:
- Oversee and guide the clinical team while driving trial activities at country or regional level
- Monitor project timelines, patient enrollment, data cleaning, compliance, and corrective and preventive measures
- Review monitoring visit reports and ensure reporting compliance across the region
- Coordinate communication among Monitors, Site Management Associates, Regional Project Leads, and Project Managers
- Lead country-level project team calls and provide status updates and reports
- Provide project-specific training and prepare training materials
- Supervise source data verification, data-query follow-up, and site-level study-risk management
- Ensure proper handling, accountability, reconciliation, and return of investigational products and clinical study supplies
- Review essential study documents and supervise ISF/TMF reconciliation
- Ensure site-level data integrity and compliance
- Collaborate on investigator/site feasibility, identification, and study startup
- Manage query resolution, including Central Monitoring observations
- Coordinate safety information flow and protocol/process deviation reporting
- Manage clinical supplies with vendors at country and regional levels
- Maintain study-specific and corporate tracking systems
- Coordinate and conduct supervised monitoring visits
- Manage site contracting and payments
- Conduct audit preparation visits, participate in site audits, and coordinate resolution of findings
- Oversee CAPA development and implementation
- Coordinate process-deviation review, management, and reporting
- Conduct initial training and authorization monitoring visits for Monitors
- Mentor newly promoted Lead CRAs
- Deliver training and presentations at Investigator Meetings
- Ensure subject recruitment targets and project timelines are defined, communicated, recorded, and met
- Ensure timely information flow with trial sites regarding Adverse Events and protocol/process deviations
- Supervise Site Management Associates handling documents and laboratory supplies
- Support preparation of regulatory and ethics committee submission packages
Requirements:
- Relevant educational background such as MD, MPharm, RN, or a college/university degree in Life Sciences, or equivalent combination of education, training, and experience
- Minimum 4 years of site monitoring experience
- Participation in global clinical projects as a Lead Monitor or equivalent qualification level
- Experience monitoring sites in the US
- Experience with all types of monitoring visits in Phase II and/or III
- Strong Oncology experience preferred
- Experience in Radiation Therapy, Radiopharmaceuticals, CAR-T Therapy, other Cell Therapy, Gene Therapy, or Nuclear Medicine preferred
- Strong experience in GI, including Crohn's, Ulcerative Colitis, or IBS, preferred
- Full working proficiency in English
- Proficiency in MS Office applications
- Ability to plan and multitask in a dynamic team environment
- Excellent communication, collaboration, and problem-solving skills
- Ability to travel
Benefits:
- Remote work
- Career growth opportunities
- Learning new things while growing with the company
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